tq05105 tablet for myelofibrosis treatment in ruxolitinib-resistant or intolerant patients

Conditions: Myelofibrosis

Summary: this is an open, single-arm, multi-center clinical study designed to evaluate the efficacy of tq05105 tablets in patients with intermediate-risk and high-risk myelofibrosis.


Eligibility criteria:
inclusion criteria: * subjects voluntarily participated in this study, signed informed consent forms, and demonstrated good compliance； * age: 18 or older (when signing the informed consent form); eastern cooperative oncology group (ecog) performance status (ps) score of 0 or 2; life expectancy ≥ 24 weeks; * patients diagnosed with primary myelofibrosis (pmf), post polycythemia vera myelofibrosis (post-pv mf), or post essential thrombocythemia myelofibrosis (post-et mf); * according to the dynamic international prognostic scoring system (dipss), patients with intermediate or high risk of bone marrow fibrosis were evaluated; * patients with poor efficacy or intolerant of ruxolitinib; * spleen enlargement; * peripheral blood primary cells and bone marrow primary cells were ≤10%; * no growth factor, colony stimulating factor, thrombopoietin or platelet transfusion was received within 2 weeks before the examination, and the blood routine indexes met the requirements within 7 days before the first administration; * the main organ function is normal; * men and women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during the study period and within 6 months after the end of the study. serum human chorionic gonadotrophin（hcg）test is not negative within 7 days before the first administration and must be non-lactating patients. exclusion criteria: * patients who have previously received allogeneic stem cell transplantation, or received autologous stem cell transplantation within 3 months before the first administration, or recently planned stem cell transplantation; * previous treatment with jak inhibitors(except ruxolitinib); * patients who have previously undergone splenectomy, or received splenic radiotherapy within 6 months before the first administration; * other malignancies within 3 years prior to first administration or currently present; * patients with multiple factors (such as inability to swallow, postoperative gastrointestinal resection, acute and chronic diarrhea, intestinal obstruction, etc.) affecting oral or absorption of drugs; * the non-hematological toxicity caused by previous treatment did not return to grade≤1; * major surgical treatment or significant traumatic injury within 4 weeks prior to first administration; * presence of congenital bleeding disorder and congenital coagulopathy; * patients who had arterial/venous thrombosis events within 6 months before the first administration; * have a history of mental drug abuse, or have a mental disorder; * active or uncontrolled severe infection; * active hepatitis b virus (hbv) infection, or hepatitis c virus (hcv) infection and hcv rna positive; * patients with ≥ grade 2 myocardial ischemia or myocardial infarction, arrhythmia, qt interval prolongation and ≥ grade 2 congestive heart failure; * unsatisfactory blood pressure control despite standard therapy; * patients with renal failure requiring hemodialysis or peritoneal dialysis; * patients newly diagnosed with pulmonary interstitial fibrosis or drug-related interstitial lung disease within 3 months before the first administration; * patients with a history of immunodeficiency disease or organ transplantation; * patients with epilepsy requiring treatment; * use of any mf medications, any immunomodulators, androgens, any immunosuppressive agents, erythropoietin, aspirin \> 100 mg/day within 2 weeks prior to first administration; * patients who have received chinese patent medicines with anti-tumor indications specified in the approved drug package insert of china national medical products administration (nmpa) within 2 weeks before the first administration; * patients with uncontrolled pleural effusion, pericardial effusion or ascites; * there was a history of attenuated live vaccine inoculation within 4 weeks before the first administration, or attenuated live vaccine inoculation was planned during the study period; * people with known hypersensitivity to the study drug and excipients; * patients diagnosed as active autoimmune diseases within 2 years before the first administration; * those who participated in and used other anti-tumor clinical trial drugs within 4 weeks before the first administration; * according to the judgment of the investigators, some situations seriously endanger the safety of the subjects or affect the subjects to complete the study.